The planning, implementation and publication of a complex intervention trial CFS: the PACE Trial

[Dolphin]

This journal accepts e-letters (which are also considered for publication) so it's an opportunity to challenge the trial. I would think ideally one would need to include at least a couple of references.

Free full text: http://pb.rcpsych.org/content/early/2014/07/14/pb.bp.113.045005.abstract

SPECIAL ARTICLE

The planning, implementation and publication of a complex intervention trial for chronic fatigue syndrome: the PACE trial

The Psychiatric Bulletin

Peter D. White1,
Trudie Chalder2 and
Michael Sharpe3

1 Queen Mary University of London
2 King’s College London
3 University of Oxford

Correspondence to Peter D. White (p.d.white@qmul.ac.uk)

Declaration of interest P.D.W. has carried out voluntary and paid consultancy work for the UK Government and a reinsurance company. T.C. has received royalties from Sheldon Press and Constable and Robinson. M.S. has carried out voluntary and paid consultancy work for the UK Government, consultancy work for an insurance company and has received royalties from Oxford University Press.

Abstract

The PACE trial was a four-arm trial of specialist medical care, compared with specialist medical care with a supplementary therapy: adaptive pacing therapy, cognitive-behavioural therapy or graded exercise therapy, for patients with chronic fatigue syndrome.

The trial found that both cognitive-behavioural and graded exercise therapies were more effective than either of the other two treatments in reducing fatigue and improving physical disability.

This paper describes the design, conduct and main results of the trial, along with a description of the challenges that had to be overcome in order to produce clear answers to the clinically important questions the trial posed.

 

[Esther12]

Our deliberate policy, to help allay concerns about the trial,
was to be as transparent as possible regarding what we did,
while protecting medical confidentiality and our staff; this
included publishing the protocol and the statistical analysis
plan,4,23 and paying for open access to all publications.

Ho-ho.

Whole paper seems to say very little really.

 

[Dolphin]

Whole paper seems to say very little really.

Yes, except try to claim that the results are clear (success for CBT and GET in various ways) and then have a few swipes at dissenters/people who looked for more data.

 

[Esther12]

No mention of their decision to drop actometers, problems with relying on questionnaires as outcome measures, their 'recovery' criteria changes, etc.

 

[Dolphin]

No mention of their decision to drop actometers, problems with relying on questionnaires as outcome measures, their 'recovery' criteria changes, etc.

Plenty of material for responders to get their teeth into.

 

[Bob]

The trial found that both cognitive-behavioural and graded exercise therapies were more effective than either of the other two treatments in reducing fatigue and improving physical disability.

CBT & GET were not more effective than SMC. The abstract contains only three sentences, and one of them (quoted) is incorrect. So that doesn't hold out much hope for the rest of the paper! (I haven't read it yet.)

 

[MeSci]

CBT & GET were not more effective than SMC. The abstract contains only three sentences, and one of them (quoted) is incorrect. So that doesn't hold out much hope for the rest fo the paper! (I haven't read it yet.)

I think they're relying on the adage that, if you say something often enough, people will believe it.

 

[Bob]

I think this is new (bolded):

Analysis of the primary outcomes revealed that both CBT and GET led to significantly greater improvements in
both fatigue and physical disability than did either SMC or APT. The adjusted effect sizes ranged from 0.5 to 0.8. To our surprise, there were no significant differences between APT and SMC in either primary outcome.

 

[Seven7]

Maybe some poeple can vonluteer that understand this better (statistical analisys and such stuff). I think this is a great opportunity for Advocacy. I have terrible english if not I would write.
My biggest issue is realted to the raw data release, and the mistery around it. They can scratch all the names they want.

 

[Dolphin]

(In case anyone missed it)
The journalist, David Tuller DrPH, has today posted a substantial piece on the PACE Trial:

TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome Study
http://www.virology.ws/2015/10/21/trial-by-error-i/

There's an introduction and summary at the start if you don't want to take on the whole thing.

It's being discussed in this PR thread:
http://forums.phoenixrising.me/inde...he-pace-chronic-fatigue-syndrome-study.40664/

ME Network have also posted their own summary piece:
http://www.meaction.net/2015/10/21/david-tuller-tears-apart-pace-trial/